The following data is part of a premarket notification filed by Iogyn, Inc. with the FDA for Iogyn System.
Device ID | K141848 |
510k Number | K141848 |
Device Name: | IOGYN SYSTEM |
Classification | Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar |
Applicant | IOGYN, INC. 20195 STEVENS CREEK BOULEVARD SUITE 120 Cupertino, CA 95014 |
Contact | Rich Christensen |
Correspondent | Rich Christensen IOGYN, INC. 20195 STEVENS CREEK BOULEVARD SUITE 120 Cupertino, CA 95014 |
Product Code | PGT |
CFR Regulation Number | 884.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-09 |
Decision Date | 2014-08-29 |
Summary: | summary |